A randomized controlled study was performed to evaluate the efficacy of intrapleural and systemic administration of
OK-432, streptococcus preparation, in patients with cancerous
pleurisy. A total of 53 patients were accessed to the study: 29 patients for the
OK-432 group and 24 patients for the control group. Intrapleural instillation of 50 mg of
adriamycin and a
combination chemotherapy of MFC (
mitomycin C 0.08 mg/kg, 5-FU 10 mg/kg,
ara-C 0.8 mg/kg iv, weekly) were administered in both groups. In the
OK-432 group intrapleural instillation of 2 units of
OK-432 was administered daily until disappearance of
pleural effusion; thereafter, 2 to 5 units of
OK-432 were administered intradermally every other day. Patients with stage III in the
OK-432 group survived significantly longer than those in the control group (P less than 0.05), but there was no significance between in patients with stage IV of both treatment groups. Also patients with
PPD negative skin reaction at the time of beginning of treatment in the
OK-432 group survived significantly longer than those in the control group (P less than 0.001), but there was no significance between both treatment groups in patients with
PPD positive skin reaction at the time of beginning of treatment. Eighteen (62%) of 29 patients treated with
OK-432 had a
fever, but well tolerated.